2021-10144. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Formative Research on Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid Misuse Among Children, Youth, and Families in Tribal American Indian and Alaska Native (AI/AN) Communities” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on July 2,2020 to obtain comments from the public and affected agencies. CDC received three comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone]. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Formative Research on Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid Misuse Among Children, Youth, and Families in Tribal American Indian and Alaska Native (AI/AN) Communities—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Adverse childhood experiences (ACEs) are preventable, potentially traumatic events that occur in childhood (0-17 years) such as experiencing violence, abuse, or neglect; witnessing violence in the home; and having a family member attempt or die by suicide. There is a robust evidence base linking ACEs to a variety of poor health outcomes across the life span, including depression, alcohol and substance use disorder, and violence perpetration and victimization. The ongoing opioid epidemic is a complex and significant public health crisis that exposes children to opioid misuse, violence, and other ACEs, and challenges the ability of Health and Human Service (HHS) systems to mitigate the effects of opioid misuse and ACEs on children and families across the U.S. American Indian/Alaska Native (AI/AN) populations experience a disproportionate burden of opioid misuse and ACEs, and ACE-related health outcomes, including opioid overdose, sexual assault, and suicide attempts. The nature and consequences of ACEs in Tribal communities is unique because of historical trauma and stark socioeconomic disparities. In addition, there are gaps in the provision of adequate healthcare.

This collection addresses critical research gaps and extends efforts to prevent violence and other ACEs before they occur and to build evidence of effectiveness of community-level strategies and approaches at the outer levels of the social ecology to Tribal communities. Results from this data collection will be communicated to relevant public health officials and community stakeholders in the study locations. These local public health officials and community stakeholders will use the study results to guide strategies to further strengthen their local prevention efforts within their regions.

Data collection methods used in this qualitative study include well-established qualitative methods, including in-depth open-ended individual interviews and focus groups. Quantitative methods include brief structured surveys. There will be a total of six Tribal communities (three urban and three rural) in regions identified with higher opioid overdose mortality rates relative to other areas in Indian Country. Due to COVID-19, at the time of the focus groups/interviews, social distancing and public health safety measures will be implemented, including considerations for phone/virtual meetings instead of in-person sessions.

The total estimated annualized burden hours are 441. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Adults 18 years or older affected by the opioid epidemic (e.g., parents/caregivers of AI/AN children, Tribal Elders) living in Tribal urban and rural/reservation communities	Information Letter Telephone screening Confirmation email/letter	160 160	1 1	5/60 25/60
		120	1	5/60
	Reminder email	120	1	5/60
	Informed Consent	120	1	25/60
	Demographic Survey	120	1	25/60
	Focus group/interview	44	1	2
	Focus group/interview	64	1	2
	Focus group/interview	12	1	2

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.